Institutional Ethics Committee · 2016-09-15 · Institutional Ethics Committee of CSJM University, Kanpur, UP, India The Institutional Ethics Committee (IEC), CSJM University, Kanpur,

Standard Operating Procedures of Ethics Committee

Institutional Ethics Committee, CSJM University, Kanpur 1 | P a g e

Institutional Ethics Committee

Standard Operating Procedures

Chhatrapati Shahu Ji Maharaj University

Kanpur-208024 U.P., India



Standard Operating Procedures

for

Institutional Ethics Committee of CSJM University, Kanpur, UP, India

The Institutional Ethics Committee (IEC), CSJM University, Kanpur, U.P. was constituted by the

Honourable Vice Chancellor, CSJM University, according to guideline of Indian Council of Medical

Research [(ICMR) (Ref. No. CSJMU/Gen.Admin/111/2016, dated 18/06/2016)] for a period of

three years.

S.No. Name Address Designation

1. Prof. Rakesh Kumar Dixit

(MBBS, MD)

Dept. of Pharmacology &

Therapeutics

King George's Medical

University U.P., Lucknow

Chairperson

2. Dr. Yogendra Narayan Verma

(MBBS, MD)

Lecturer, Dept. of Pathology

GSVM Medical College,

Kanpur

Member

(Basic Medical

Scientist)

3. Dr. Praveen Katiyar

[MBBS, Ph.D.(KGMU)]

Coordinator & Assistant

Professor

University Institute of Health

Sciences, CSJM University,

Kanpur

Member

(Basic Medical

Scientist)

4. Dr. B.P. Priyadarshi

(MBBS, MD)

Associate Professor

Govt. Medical College,

Kannauj

Member

(Clinicians)

5. Dr. Gaurav Gupta

(MBBS, MD, DM)

Oncologist & ECMO

Ram Manohar Lohia Institute

of Medical Sciences,

Lucknow

Member

(Clinicians)

6. Shri Naveen Mishra

(LLB)

Advocate

District Court, Kanpur

& High Court, Allahabad

Member

(Legal expert)

7. Shri Dharmendra Kumar Singh

(M.Sc.)

Founder & Secretary

Samrat Ashok Manav Kalyan

Evam Shiksha Samiti

(SAHWES)

Kanpur

Member

(NGO)

8. Dr. ShyamBabu Gupta

(Ph.D.)

Director, Deen Dayal Shodh

Kendra, CSJMU, Kanpur

Member

(Philosopher/ethicist

/ theologian)

9. Smt. Pratibha Sharma

(B.A)

H.No. 117/Q/94-D, Sharda

Nagar, Kanpur

Member

(Lay person)

10. Dr. Manish Kumar Gupta

(M.Sc., M.Tech., Ph.D.)

Assistant Professor

Dept. of Bioinformatics,

UIET, CSJM University,

Kanpur

Member Secretary



I. Short Description of SOP:

The following may be called as “Standard Operating Procedures for the Institutional ethics

committee (IEC) of CSJM University, Kanpur”.

II. Objective:

The objective of this SOP is to contribute to the effective functioning of the IEC-CSJMU so

that a quality and consistent ethical review mechanism for health and biomedical research is

put in place for all proposals dealt by the Committee as prescribed by the Ethical guidelines

for biomedical research on human subjects of ICMR.

III. Role of IEC-CSJMU:

IEC-CSJMU will review and approve all types of research proposals involving human

participants with a view to safeguard the dignity, rights, safety and well being of all actual and

potential research participants. The goals of research, however important, should never be

permitted to override the health and well being of the research subjects.

The IEC-CSJMU will take care that all the cardinal principles of research ethics viz.

Autonomy, Beneficence, Non - maleficence and Justice are taken care of in planning, conduct

and reporting of the proposed research. For this purpose, it will look into the aspects of

informed consent process, risk benefit ratio, distribution of burden and benefit and provisions

for appropriate compensations wherever required. It will review the proposals before start of

the study as well as monitor the research throughout the study until and after completion of

the study through appropriate well documented procedures for example annual reports, final

reports and site visits etc. The committee will also examine compliance with all regulatory

requirements, applicable guidelines and laws. The SOPs will be updated periodically based

on the changing requirements.

The mandate of the IECs will be to review all research projects involving human subjects to

be conducted at the Institute, irrespective of the funding agency.

IV. Composition of IEC-CSJMU:

IEC-CSJMU should be multidisciplinary and multisectorial in composition. Independence and

competence are the two hallmarks of an IEC-CSJMU.

The number of persons in an ethical committee should be kept fairly small (7-9 members). It

is generally accepted that a minimum of five persons is required to compose a quorum. There

is no specific recommendation for a widely acceptable maximum number of persons but it

should be kept in mind that too large a Committee will make it difficult in reaching consensus

opinions. 12-15 is the maximum recommended number.

The Chairperson of the Committee should preferably be from outside the Institution and not

head of the same Institution to maintain the independence of the Committee. The Member

Secretary who generally belongs to the same Institution should conduct the business of the

Committee. Other members should be a mix of medical / non-medical scientific and non-

scientific persons including lay public to reflect the differed viewpoints.



The composition may be as follows :-

1. Chairperson

2. 1-2 basic medical scientists.

3. 1-2 clinicians from various Institutes

4. One legal expert or retired judge

5. One social scientist / representative of non-governmental voluntary agency

6. One philosopher / ethicist / theologian

7. One lay person from the community

8. Member-Secretary

V. Authority under which IEC-CSJMU is constituted:

The Institutional Head, Hon'ble Vice Chancellor, CSJM University, Kanpur will constitute the

IEC-CSJMU.

Membership requirements:

a. The duration of appointment is initially for a period of 3 years.

b. At the end of 3 years, as the case may be, the committee is reconstituted, and 50% of the

members will be replaced by a defined procedure.

c. A member can be replaced in the event of death or long-term non-availability or for any

action not commensurate with the responsibilities laid down in the guidelines deemed unfit

for a member. .

d. A member can tender resignation from the committee with proper reasons to do so.

e. All members should maintain absolute confidentiality of all discussions during the meeting.

f. Members of Ethics committee will declare conflict of interest with proponent and/or projects

at the initiation of meeting. They will not be part of deliberations on projects submitted by

self, siblings, spouse, children, parents and first degree relatives. In case they abstain from

participation for other reasons they have to agree with the decisions of the Ethics Committee.

VI. Frequency of meetings:

The Ethics committee will meet about once in 6 months or as per the requirement.

VII. Quorum requirements:

The minimum of 5 members are required to compose a quorum. All decisions should be

taken in meetings and not by circulation of project proposals.

VIII. Offices:

The Chairperson will conduct all meetings of the IEC-CSJMU. If for reasons beyond control,

the Chairperson is not available, the Deputy Chairperson or an alternate Chairperson will be

elected from the members by the members present, who will conduct the meeting. The

Member Secretary is responsible for organizing the meetings, maintaining the records and

communicating with all concerned. He/she will prepare the minutes of the meetings and get it

approved by the Chairperson before communicating to the researchers with the approval of

the appropriate authority.



IX. Independent consultants:

IEC-CSJMU may call upon subject experts as independent consultants who may provide

special review of selected research protocols, if need be. These experts may be specialists in

ethical or legal aspects, specific diseases or methodologies, or represent specific communities,

patient groups or special interest groups e.g. Cancer patients, HIV/AIDS positive persons or

ethnic minorities. They are required to give their specialized views but do not take part in the

decision making process which will be made by the members of the IEC-CSJMU.

X. Application Procedures:

a. All proposals should be submitted in the prescribed application form, the details of which are

given under Documentation

b. All relevant documents should be enclosed with application form (Annexure I)

c. Required number of copies of the proposal along with the application and documents in

prescribed format duly signed by the Principal Investigator (PI) and Co-investigators /

Collaborators should be forwarded by the Head of the Departments / Institution to the ethics

committee.

d. The date of meeting will be intimated to the researcher, to be present, if necessary to offer

clarifications.

e. The decision will be communicated in writing. If revision is to be made, the revised

document in required number of copies should be submitted within a stipulated period of

time as specified in the communication or before the next meeting. (Annexure II)

XI. Documentation:

All Research proposals (6 copies along with 1 CD/DVD) shall be submitted along with the

information and documents as specified in Annexure III to the Member Secretary,

Institutional Ethics Committee at the IEC office, CSJMU, Kanpur.

Explain all anticipated ‘risks’ (adverse events, injury, discomfort) of the project. Efforts taken

to minimize the ‘risks’. For trials, proposed compensation and reimbursement of incidental

expenses and management of research related and unrelated injury/ illness during and after

research period. Description of the arrangements for indemnity, if applicable in study-related

injuries and description of the arrangements for insurance coverage for research participants,

if applicable. (Annexure IV and Annexure V)

XII. Review procedures:.

a. The meeting of the IEC-CSJMU should be held on scheduled intervals as prescribed and

additional meetings may be held as and when the proposals are received for review.

b. The proposals will be sent to members at least 2 weeks in advance.

c. Decisions will be taken by consensus after discussions, and whenever needed voting will be

done.

d. Researchers will be invited to offer clarifications if need be.

e. Independent consultants/Experts will be invited to offer their opinion on specific research

proposals if needed. The Chair may direct the secretary to obtain review by an expert prior to

consideration for ethical approval by the EC. The reviewer has to give comments in writing

on scientific merit and feasibility to assist in the decision of the EC. Chairperson will identify



the name of the external reviewer. Members of EC can suggest names of external reviewers to

the chair for approval.

f. The decisions will be minuted and Chairperson’s approval taken in writing.

XIII. Distribution of Review work:

a. New Proposal:

Review proposals have to come to full committee.

b. Revised Proposal:

In case of minor amendments the investigators will state what changes have been

made. This will be subject to approval by the Chair. If there are major modifications the Chair

may place the proposal before full committee for approval.

c. Special Case

The sponsors will now have to submit a fee of Rs. 35,000/- at the time of submission

of any new drug trial for review of Institutional Ethics Committee and Rs.10000/- for

review of modifications through a Demand Draft in favour of “Finance Officer ,

CSJM University, Kanpur”.

XIV. Element of review:

a. Scientific design and conduct of the study.

b. Approval of appropriate scientific review committees.

c. Examination of predictable risks/harms.

d. Examination of potential benefits. .

e. Procedure for selection of subjects in methodology including inclusion/ exclusion, withdrawal

criteria and other issues like advertisement details.

f. Management of research related injuries, adverse events.

g. Compensation provisions.

h. Justification for placebo in control arm, if any. .

i. Availability of products after the study, if applicable.

j. Patient information sheet and informed consent form in local language.

k. Protection of privacy and confidentiality.

l. Involvement of the community, wherever necessary.

m. Plans for data analysis and reporting

n. Adherence to all regulatory requirements and applicable guidelines

o. Competence of investigators, research and supporting staff

p. Facilities and infrastructure of study sites

q. Criteria for withdrawal of patients, suspending or terminating the study

(Annexure VI to VIII)

XV. Expedited review:

All revised proposals, unless specifically required to go to the main committee, will be

examined in a meeting of identified members convened by the Chairperson to expedite

decision making. Expedited review may also be taken up in cases of nationally relevant

proposals requiring urgent review. The nature of the applications, amendments, and other

considerations that will be eligible for expedited review can be done by circulation and there

must be an immediate response (7 days).



XVI. Waiver:

The chairperson will decide about the waiver if needed. All projects done in the institutions

should come to ethical committee which will then decide whether it is a “non-research work”

and therefore eligible for waiver. Standardized waiver form will be used by researcher at the

time of submission of proposal. (Annexure IX)

XVII. Decision Process:

a. Members will discuss the various issues before arriving at a consensus decision.

b. A member should withdraw from the meeting during the decision procedure concerning an

application where a conflict of interest arises and this should be indicated to the chairperson

prior to the review of the application and recorded in the minutes.

c. Decisions will be made only in meetings where quorum is complete.

d. Only members can make the decision. The expert consultants will only offer their opinions.

XVIII. Suggested decisions made by committee:

For all new proposals reviewed the committee will come to one of the following decisions:

a. Approval as submitted

b. Withheld approval contingent upon specific revisions – Chair alone will approve the

revisions.

c. Tabled for substantive change – Full EC will approve changes.

d. Disapproved

If a proposal has been disapproved then the person could resubmit it for review to the

committee.

XIX. Communicating the decision:

a. Chairperson will sign the final minutes.

b. Decision will be communicated by the Member Secretary in writing to the PI/Research

scholar within two weeks after the meeting at which the decision was taken. All the approvals

will be valid for three years or for the duration of the project.

c. Suggestions for modifications, if any, should be sent by IEC-CSJMU.

d. Reasons for rejection should be informed to the researchers.

e. The schedule / plan of ongoing review by the IEC-CSJMU should be communicated to the PI.

XX. Follow up procedures:

a. Annual progress report will be reported in a standardized format. (Annexure X)

b. Reports should be submitted at prescribed intervals for review.

c. Final report should be submitted at the end of study.

d. All Serious Adverse Events (SAEs) and the interventions undertaken should be intimated.

e. Protocol deviation, if any, should be informed with adequate justifications.

f. Any amendment to the protocol should be resubmitted for renewed approval.

g. Any new information related to the study should be communicated.

h. Premature termination of study should be notified with reasons along with summary of the

data obtained so far.



i. Change of investigators / sites should be informed.

XXI. Record keeping and Archiving:

a. Curriculum Vitae (CV) of all members of IEC-CSJMU.

b. SOPs of IEC-CSJMU

c. Copy of all study protocols with enclosed documents, progress reports, and SAEs.

d. Minutes of all meetings duly signed by the Chairperson.

e. Copy of all existing relevant national and international guidelines on research ethics and laws

along with amendments.

f. Copy of all correspondence with members, researchers and other regulatory bodies.

g. Final report of the approved projects.

h. All the documents related to research proposals will be archived for a minimum period of 3

years in the institute, following the completion /termination of the study.

XXII. Updating IEC-CSJMU members:

a. All relevant new guidelines should be brought to the attention of the members.

b. Members should be encouraged to attend national and international training programs in

research ethics for maintaining quality in ethical review and be aware of the latest

developments in this area.



Annexure- I

Application for Ethical Committee Approval

To,

The Chairperson/Member Secretary

Institutional Ethics Committee

CSJM University, Kanpur, UP

Subject : Regarding submission of Research Proposal for Ethical Approval.

Dear Sir/Madam,

My topic of research project is

"....................................................................................................................................................

......................................................................................................................................................

......................................................................................................................................................

................................................................................................................." I am submitting this

research project for the ethical clearance certificate approval from Institutional Ethics

Committee of CSJM University, Kanpur.

Kindly do the needful.

Date :

With regards

Encl. 1. CV of PI/CoPI/Collaborators

2. Related annexures

Name and Signature of

PI/Co PI/ Collaborator with

Address...................................

.................................................



Annexure - II

Standard Format for Submission of revised/additional Document

Format for submission of revised/additional documents, protocols and information regarding

already approved projects to be submitted by the Principal Investigator (PI) (Two copies of this

form along with the revised documents to be submitted)

1. IEC Reference No:

2. Approval Date and Number:

3. Title:

4. Principal Investigator:

5. Purpose of this submission:

6. New documents being submitted: Please list the documents being submitted alongwith

the differences from the previously approved documents in a tabular form as below:

S. No. List of Documents being submitted List the modifications/revisions made from

previously approved proposal, wherever

applicable

Place: Signature PI/Collaborator

Date: Name:



Annexure – III

Standard Format for Executive Summary

to be submitted for Ethical Approval

(up to 5 pages)

1. Title of Project:

2. Investigators (Name & Affiliation):

3. Collaborators (if any):

4. Potential Funding Agency:

5. Background and Brief Review of Literature with references:

6. Hypothesis and Objectives:

7. Study design and methods:

8. Intervention:

9. Inclusion and exclusion criteria:

10. Sample size for primary outcomes:

11. Data Management and Analysis:

12. Ethical clearances:

13. Time Line:

Signature of Principal Investigator: _______________________

Date: _______________________



Annexure – IV

MEMORANDUM OF UNDERSTANDING

This Memorandum of understanding (hereinafter called MOU) between Chhatrapati Shahu Ji

Maharaj University, Kanpur, U.P., India through Registrar, IEC-CSJMU, Kanpur (herein after called

CSJMU, Kanpur), the Principal investigator of the Project (the Second

Party_____________________________________________________ (herein after

called______________________________________________) and the sponsoring Agency (the third

Party ____________________________________________________ (herein after

called_____________________________________________) of the Project entered into on this

______________ (day) _____________ (month)___________(year).

Preamble :

Whereas CSJMU Kanpur is a University, established by Govt. of Uttar Pradesh for

providing education and research of high order.

Whereas (the third Party) _____________________________________________

________________________________________________________________________

________________________________________________________________________

Whereas CSJMU Kanpur and (the second party) _____________________________

_________________________________________________________are willing to jointly

participate in the development of _____________________________________

________________________________________________________________________

The coordinator of the project will be

___________________________________________________________ (name and designation of

the faculty member responsible from CSJMU, Kanpur) (Second Party). The other coordinator of the

project will be _________________________________ (name and designation of person responsible for

third party).



Scope of MOU

This MOU will cover the joint efforts of Chhatrapati Shahu Ji Maharaj

University, Kanpur, (First Party), the Principal investigator of the Project (Second

Party) and

________________________________ (third party) in the area of ___________________________________________________________ _____________________________________________________________ (specify the area of work jointly to be done)

Furnish full details of the work to be done: 1.

2.

3.

4.

5. Responsibilities of CSJMU, Kanpur 1.

2.

3.

4.

5.

Responsibilities of Second Party 1.

2.

3.

4.

5.



Responsibilities of Third Party 1.

2.

3.

4.

5. Administration: Joint responsibilities of the project will be with Chhatrapati Shahu Ji Maharaj

University, U.P., Kanpur (first Party), the Principal investigator of the Project (Second

Party) and _____________________________________________________________(third party) Financial Arrangements: Funds for the projects will be from ___________________________________________ ___________________________________________________________________________ ____________ (name the funding agency) and the proportion of the funds to be

released to CSJMU, Kanpur will be Rs. _______________________ (specify the

amount).

The following equipment/consumables/supplies will be provided to CSJMU,

Kanpur by (third Party) ________________________________________

(This is for MOU’s involving grant of

equipment/consumables/supplies)

1.

2.

3.

4.

5.



Intellectual Property Rights:

1. The R & D information generated shall be shared by both the collaborating parties.

2. Any publication shall be by mutual consent of second and third party.

3. Patents and other benefits, arising out of the project if any, shall be shared between all

three parties.

4. For projects identified as having a distinct potential of generating know how

leading to commercial applications NRDC (National Research Development Corporation of India) Guidelines will be followed.

NRDC Guidelines:

1. To bring to the notice of the Investigator, prospective user of the technology being developed.

2. To do market research about the product and bring out a comprehensive study

about the market potential for attending entrepreneur.

3. For effective coordination between the laboratory generating the knowhow and the entrepreneur.

4. To take such other steps as may facilitate the communication of know how.

5. NRDC will retain 40% of the royalty/premia and the remaining 60% will be

sent to the CSJMU, Kanpur, generating the knowhow. The sharing of 60%

between the CSJMU, Kanpur and the project investigator team may be

decided by the CSJMU, Kanpur.

Duration of MOU : This MOU will be in force for a period of __________________(years) from the date

of its signing).

Amendments to the MOU:

Amendments if any, before the expiry of this MOU shall be made in writing by the

authorized representatives of CSJMU, Kanpur and

__________________________________ ___________________________ (third party) after mutual agreement.

Resolution of Dispute: Any dispute or difference between the collaboration parties shall be amicably resolved

by either through mutual consultation or arbitration. The Vice Chancellor, Chhatrapati

Shahu Ji Maharaj University, Kanpur, U.P. will be the arbitrator and the decision of

the arbitrator shall be final.



Jurisdiction and Courts: The MOU shall be governed by Laws of India and the parties agree to be subject to

jurisdiction of competent courts at Allahabad i.e. High Court and Subordinate courts at

Kanpur in addition to other places in India only.

Seal of the Parties: In witness thereof Parties hereto have signed this MOU on the day, month and year

mentioned herein before.

Parties:

(1) Signed and delivered for (2) Signed and delivered for and behalf of CSJMU, Kanpur (First Party) and behalf of (Second Party)

Signature

Name

Designation

Seal

Signature

Name

Designation

Seal

(3) Sign and delivered for and behalf of (Third Party)

Signature

Name

Designation

Seal

___________________________________________________________________________

Note : This is to be written on stamp of Rs. 100/-



Annexure – V

INDEMNITY AGREEMENT

The indemnity agreement is between Chhatrapati Shahu Ji Maharaj University,

Kanpur U.P., India (hereinafter CSJMU, Kanpur) through Principal Investigator and

___________________________________________________________________________

__________________________________ the authorized Signatory of Second party (Name of the second party/sponsor)

(hereinafter SPONSOR) whereas CSJMU, Kanpur engages in medical research that involves experimental and

investigational products, drugs devices or therapy and

whereas SPONSOR owns or has right to such experimental or investigational products, drugs

devices specifically as it relates to this agreement, products devices, drugs shall mean the

following: 1.

2.

3.

4.

5. Whereas CSJMU, Kanpur and SPONSOR have agreed that CSJMU, Kanpur will use

SPONSOR’s experimental and investigational products, devices, drugs for research

purposes.

Now therefore, the parties agree as follows: 1. Undesirable side effects, injuries, illness or reactions:

The SPONSOR agrees to indemnify, protect, defend and hold harmless CSJMU,

Kanpur, its officers, employees against cost or expenses associated with the diagnosis

and treatment of undesirable side effects, injuries, illness or reactions that arise

specifically from SPONSOR’s products, devices, drugs.

2. Loss, Damage or Liability:

The SPONSOR agreed to indemnify, protect, defend and hold harmless CSJMU,

Kanpur, its officers, employees from any loss, damage or liability they may suffer or

incur as a result of claims or demands made against them that arise specifically from

research involving SPONSOR’s products, devices, drugs.



3. Insurance:

The SPONSOR agrees to maintain inforce at its sole cost and expense with reputable

insurance companies, Insurance of a type and in amounts equal to atleast

_______________________________________ per occurrence combined

(specify the amount of money)

single limit and _______________________________________________ annual (specify the amount of money)

aggregate. CSJMU, Kanpur shall have the right to request the appropriate certificates

of insurance from SPONSOR for purposes of ascertaining the sufficiency of

coverage.

4. Attorneys and legal coverage:

The SPONSOR agrees to provide, at its own expense, attorneys to defend against any

claims made or action filed against CSJMU, Kanpur its officers, employees. The

SPONSOR also agrees to pay any settlement amounts or judgments levied against

CSJMU, Kanpur or any losses or expenses incurred by CSJMU, Kanpur resulting

from such claims or action.

5. Cooperation of parties

CSJMU, Kanpur (Principal Investigator) agrees to notify promptly, SPONSOR in

writing when any undesirable side effect, injury, illness or reaction arises from

research involving SPONSOR’s products, devices, drugs. CSJMU, Kanpur agrees to

cooperate with SPONSOR in defending any claim or action covered by this

agreement. The SPONSOR agrees to consult on a regular basis with CSJMU, Kanpur

regarding the defense or settlement of any claim or action. Neither party will

compromise or settle any claim or action without prior written consent of the other

party.

6. Institutional Overhead

10% of total budget (less the cost of equipment) be provided as institutional overhead.

7. Other

This indemnity agreement does not displace, supercede or in any way limit any other

agreements between the parties.

Indian agents can sign on behalf of foreign sponsor.

Tripartite agreement is needed.



Signed for and on behalf of CSJMU, Kanpur

Name____________________________

Signature_________________________

Seal_____________________________

Date____________________________

Signed for and on behalf of SPONSOR

Name____________________________

Signature_________________________

Seal_____________________________

Date____________________________

___________________________________________________________________________

Note : Indemnity Agreement is to be written on stamp of Rs. 100/-



Annexure -VI

Standard Format Informed Consent Form in English & Hindi

Title of Project:

Investigators (Name & Affiliation):

Collaborators (if any):

Potential funding agency:

Patient/Parent/Guardian Consent

PART 1

1. Purpose of the study

2. Study procedures

3. Risk from the study

4. Benefits from the study

5. Complications

6. Compensation

7. Confidentiality

8. Rights of the participants

9. Alternatives to participation in the study

PART 2

Patient/Parent/Guardian Consent

I have had the study explained to me and have read the contents of this form/had the contents of this

form read to me. I have been given the opportunity to ask question and have them answered

to my satisfaction.

I am willing for my child to be enrolled in the study

Name of subject:

Signature of Patient/Parent/Guardian:

Name of Patient/Parent/Guardian:

Date:

Relationship to subject :

Investigator’s statement:-

I, the undersigned have explained to the parent/guardian in a language she/he understands the

procedures to be followed in the study and risks and benefits.

Signature of the Investigator: Date:

Name of the Investigator:

Signature of the Witness: Date:

Name of the Witness:



Annexure -VII

PARTICPANT INFORMED CONSENT FORM (PICF)

(For the Subject / Patient)

The advantages and disadvantages of the research in which I am expected to participate, for which I have to donate .........................................................sample has been explained to me. I willingly, under no pressure from the researcher – (i) agree to take part in this research and agree participate in all investigation which will help acquire knowledge for the benefit of the mankind. (ii) agree to donate my ........................................................... My consent is explicitly not for disclosing any personal information. For disclosing any such personal information obtained from the investigations conducted on my samples, further consent should be obtained. I have been informed that researcher (...................................................) will take my prior consent before they draw benefits from research based on my samples. Name - Subject/Patient Witness Principal Investigator Signatures - Subject/Patient Witness Principal Investigator

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Annexure-VIII

CSJM University, Kanpur

Check List for submitting Research Proposals for clearance of Ethical Committee

PART I

1. Title of the Project :__________________________________________________________

__________________________________________________________

__________________________________________________________

2. Investigator's Name :__________________________________________________________

& Department

3. Source of Funding :_________________________________________________________

4. Check List

S.No. Particulars Yes No If No (Give

Reason)

a. Executive Summary

(Proposal/Modification)

b. New Proposal for Modification

c. Informed Consent Form (a) English

(b) Hindi

d. Budget

e. Memorandum of Understanding

(Industry Sponsored Projects)

5. Whether the project involves

5.1 Clinical trial with new drug(s) device(s) approved by DCGI Yes No

5.2 Clinical trial with existing drug(s) device(s) approved by DCGI Yes No

5.3 Clinical trial with traditional medicine from Ayurvedic/ Unani/ Yes No

Homoeopathy/Tribal System

5.4 Note of the above Yes No

CAUTION NO DRUG/DEVICE IS TO BE USED UNLESS APPROVED BY DRUG

CONTROLLER OF INDIA (DCGI)

If answer to 5.1. is yes, kindly furnish evidence of experimental and clinical safety of the drug (Use

separate sheets).



6. If the human material to be collected is human tissue specify the tissue (____________________)

6.1 It will be obtained by Operation/Biopsy/Abortion/Autopsy Other

(Specify____________________________________________________________________

______________________________

6.2 Whether the procedure required to obtain the tissue is otherwise

indicated for the management of the patient. Yes No

6.3 Whether the project involves normal human tissue Yes No

If answer to 6.2 is yes please explain the full procedure and justify

collection and use of material (Use separate sheets).

6.4 Will it be collected in amounts in excess of which would otherwise

be collected for the management of patient. Yes No

If answer to 6.4 is yes then specific the excess amount

......................................ml at a time

......................................ml total

6.4(a) Will it be collected by extra peripheral venous puncture which

would otherwise be required for the management of the patient. Yes No

If answer to 6.4(a) is yes then specify the total number of peripheral

venous punctures (________________________________________

6.4(b) Will it be collected by a method which would otherwise not Yes No

be required for the management of the patient?

If answer to 6.4(b) is yes then specify the method (___________________________)

7. Any other human material (Specify ______________________________________________) If

answer to 7 is yes then answer 7.1 and 7.2 below

7.1 Specify the method of collection (_______________________________________________

_________________________ _______________________________________________)

7.2 Specify the amount to be collected

(__________________________________________________)



PART II

(DECLARATION BY THE PRINCIPAL INVESTIGATOR)

I hereby declare that :

1. Voluntary written consent of the human subject will be obtained.

2. In case of children and mentally handicapped subjects/voluntary written informed

consent of the parents/guardians will be obtained.

3. The probable risk involved in the project will be explained in full detail to the

subjects/ parents/guardians.

4. Subjects/parents/guardians will be at liberty to opt out of the project at any time.

5. I will terminate the experiment at any stage, if I have probable cause to believe, in the

exercise of the good faith, skill and careful judgement required for me that

continuation of the experiment is likely to result in injury, disability of death to the

experimental subject.

Date : ______________

(Name & Signature of Principal Investigator)

Dept._______________________



PART III

(DECLARATION BY THE PRINCIPAL INVESTIGATOR/HEAD OF THE DEPT.)

1. Is the Department/University ready to undertake the responsibility of the

human subjects in case of injury?

If yes, then will it include

Transportation Charges

Hospitalization charges

Yes No

Yes No

Yes No

2. Do you think that the experiments are so designed that they would yield

meaningful results that could not be obtained by the other method?

Yes No

3. Do you think that the experiments carried put support the need for

clinical experimentation?

Yes No

4. Do you think that the experiments would be conducted in a manner to

avoid all unnecessary physical and mental suffering and injury?

Yes No

5. Do you think the experiments have been planned in a manner so that the

degree of risk to be taken would never exceed that determined by the

humanitarian importance of the problem to be solved by the

experiment?

Yes No

6. Do you think that proper preparations would be made and adequate

facilities provided to protect the experimental subject against even

remote possibilities of injury, Disability or death.

Yes No

7. Do you think that safeguards have been taken to see that the

experimentation would be conducted only by scientifically qualified

persons who possess the requisite competence, experience and qualities

to carry out the research.

Yes No

(Signature of Principal Investigator) (Signature of Head of the Dept.)

Name of PI Name of HOD

---------------------------------------------------------------------------------------------------------------------------

Date of Receiving _________________ (Signature)

On behalf of IEC



Annexure - IX

INSTITUTIONAL ETHICS COMMITTEE

CSJM UNIVERSITY, KANPUR U.P.

Human Subjects Review Waiver Form

Protocol/Project Title:

Principal Investigator (s):

Determination: CSJMU-Ethics Committee review is NOT required for this project,because:

I. Activity is not research. Activity is a disease control activity with no research

component.

A. Epidemiologic/endemic disease control activity, data collected are directly relevant to disease control needs.

B. Surveillance activity, data used for disease control program or policy purposes.

C. Demonstration project which may or may not include evaluation.

OR

II. Activity is not research NOT involving identifiable human subjects.

All of the following are required:

A. No contact with human subjects is/was involved for this subject...................

and...................

B. Data or specimens are/were collected for another purpose ..............................................

and .......................

C. No extra data/specimens are/were collected for this purpose.....................

and..........................

D. Indentify information was (or will be) either not obtained or was (or will be) removed

before analysis so that data cannot be linked or re-linked with identifiable human

subjects.

OR

III. Activity is research involving collection/analysis of data about units other than

individual persons.

Additional Comments:

However, Ethics Committee review is not required in this instance research, proper consideration must be given to:

1. the risks to the subjects,

2. the anticipated benefits to the subjects and others,

3. the importance of the knowledge that may be reasonably be expected to result,

4. the informed consent process to be employed,

5. the provisions to protect the privacy of subjects, and

6. any appropriate additional safeguards for vulnerable populations. OTHER COMMENTS

Signed :______________________________ _______________

CSJMU Ethics Committee Chairperson Date



Annexure – X

Standard Format for Annual Progress Report

(up to 5 pages)

1. Institute Ethics Committee Reference No._____________________________________

2. Title of Project: __________________________________________________________

________________________________________________________________

________________________________________________________________

3. Investigators (Name &Affiliation): __________________________________________

________________________________________________________________

________________________________________________________________

4. Collaborators (if any):

5. Potential Funding Agency:

6. Hypothesis and objectives

7. Duration of the Study:

8. Date of Starting of the study:

9. Period of Annual progress report: From__________________to____________

Signature of Principal Investigator______________________________________

Name of PI_________________________________________

Date:______________________________________

Progress:

Side Effects if any:

Amendments if Any:

Discontinuation reasons: